Presbyopia
Conditions
Brief summary
Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia
Detailed description
Multicenter, Double-Masked, Randomized, Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF Topical Ophthalmic Solution With Emmetropic Phakic and Pseudophakic Presbyopia
Interventions
DRUGBRIMOCHOL™ PF
A single drop in each eye at a visit.
DRUGCarbachol PF
A single drop in each eye at a visit.
DRUGVehicle
A single drop in each eye at a visit.
Sponsors
Visus Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female in good general health * Must have presbyopia
Exclusion criteria
* History of allergic reaction to the study drug or any of its components * Any disease or medical condition that, in the opinion of the Investigator, would prevent the subject from participating in the study or might confound study results
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in near VA | Baseline Day 1 | Percentage of subjects with 3-line improvement in near VA without the loss of at least 1 line in distance VA |
Countries
United States
Outcome results
None listed